Interventional techniques for removing disease such as atherosclerotic plaque, thrombus and other types of obstructions and partial obstructions from internal body lumens or cavities using interventional catheters are well-established. Interventional catheters may employ operating heads that break down and/or remove occlusive material using mechanical structures such as cutter assemblies, abrasive materials and/or shaped tools, excision devices, ablation instruments employing modalities such as RF, laser or radiation-induced ablation modalities, ultrasound, fluid jets or fluid agitation and the like. Other types of interventional catheters may provide fluid infusion and/or aspiration alone, or in combination with another diagnostic or treatment modality. Many of these systems involve placement of a guiding catheter and/or guide wire prior to introduction of the interventional catheter, facilitating navigation of the interventional catheter to the target operating site and manipulation of the interventional catheter at the target site.
Many material removal devices and interventional catheters incorporate mechanical aspiration systems to remove fluid, disease material and/or particulate debris from the site. Some systems incorporate, or are used in conjunction with, other mechanisms such as distal filters, for preventing material dislodged during the procedure or debris generated during the procedure from circulating in the blood stream. Some interventional catheter systems incorporate or are used in conjunction with a fluid infusion system providing delivery of fluids to an interventional site. Interventional catheter systems may also incorporate or be used in conjunction with imaging systems and other types of complementary and/or auxiliary tools and features that facilitate desirable placement and operation of the system during an interventional procedure.
One or more controllers are generally provided for operating an interventional catheter. Some types of interventional catheters employ a single operational and control component interfacing with and mounted to the interventional catheter at a proximal end of the catheter. In devices that interface with a single operating and control component, system operating components may be housed in the operating and control component, and user interface controls for operating the catheter and operating head are provided on the operating and control component. Various control features for activating and operating the interventional catheter, its aspiration and/or infusion systems, and/or its operating head may be provided. Status indicators, system read-outs and operating information may also be provided on interventional catheter operating and control components.
Some interventional catheter systems employ a console-type controller that interfaces directly with interventional catheter components, while some interventional catheter systems employ both a console-type controller that houses non-disposable components such as pumps, drive systems, electrical, electronic, vacuum and fluid control systems, and the like, as well as another intermediate control device that provides operator control options and, in some cases, feedback information. The intermediate control device is typically located at or near a proximal end of the interventional catheter, and may be positioned within or close to the sterile field during a procedure. Interventional catheter systems employing both a console-type controller and an intermediate control device are described, for example, in PCT International Publication WO 2008/042987 A2, the disclosure of which is incorporated herein by reference in its entirety. Patients may also be monitored during an interventional procedure using separate or integrated systems, such as fluoroscopic or other visualization systems, vital sign monitoring systems, and the like.
During setup of an interventional catheter system employing a control module, an operator typically connects or otherwise operably interfaces components of the interventional catheter assembly, or an intermediate control system generally designed for single patient use, to the reusable console-type control module. In many cases, this involves installing infusion and/or aspiration tubing in the console, interfacing the tubing with pump(s), infusion sources, aspiration receptacles, priming the infusion system, and the like. The operator then navigates the catheter to a desired interventional site and is ready to operate the catheter.
Some interventional catheter systems operate according to pre-set operating parameters and allow the operator to activate and inactivate the device only, without allowing the operator to select or vary operating parameters based on individual patient and intervention conditions. Some interventional catheter systems provide user operable controls that allow an operator to select or vary at least some of the interventional catheter operating parameters. Many interventional catheter systems that employ a rotating operating head, for example, provide an interface permitting the operator to control the rotational speed of the operating head during an interventional procedure. In other interventional catheter systems, control and interface systems are provided to allow the operator to select, set, adjust or otherwise configure various user selectable operating parameters and/or system settings. There may be numerous such user selectable and adjustable operating parameters and/or system settings that may be established and/or selected prior to proceeding with an intervention, or during an intervention. Suitable operating parameters depend on the nature of treatment and the disease or condition state, the patient's anatomy and condition, the specific interventional catheter in use and the operating capabilities of the interventional catheter, and the operator's preferences and expertise.
Technology for providing coded operating information in association with a single use interventional catheter assembly and conveying that coded operating information to a drive unit has been proposed. U.S. Patent Publication 2007/0073233 A1, for example, discloses a thrombectomy catheter deployment system that simplifies set-up procedures in systems employing a disposable thrombectomy pump/catheter assembly that mounts in a stand-alone drive unit for operation. The single use pump catheter system incorporates a plurality of preconnected structures, including a tubular structure, for interfacing with mating structures in the drive unit and for automatic engagement and alignment, or disengagement, of components in the single use pump/catheter assembly with the drive unit. The drive unit uses digital technology to enable multiple operating modes encoded on individual pump/catheter assemblies using barcode or radio frequency identification technology. Operating mode parameters such as pump stroke length, downstroke speed, acceleration time, and the like are encoded on the pump/catheter assembly so that, when it is mounted on the drive unit, calibration and operating mode information is automatically provided to the drive unit.
Surgical systems employing multiple surgical devices having different operational limits that are mountable on and used with a common drive system or handpiece are disclosed, for example, in U.S. Pat. No. 4,705,038 (Re. 34,556). In this system, each surgical device has an indicator on its proximal portion indicating its operational limits, and the handpiece has an automatic sensor (e.g., a magnetic sensor) for detecting and reading the indicator. When the surgical device is mounted on the handpiece and the operational limits are detected, the handpiece operates the motor drive in accordance with the operational limits coded by the surgical device. This allows multiple surgical devices, each having different operating limits and characteristics, to be operated by a common drive and controller.
Similar coding systems have been proposed for use with other types of devices, such as power toothbrushes, may permit the use of multiple detachable brush heads with a common drive housed in a handle. Coding systems for recognizing different brush heads mounted on a common handle have been developed. Systems for conveying data, such as operational data, from the brush head to the handle using RFID technology have also been developed. For example, U.S. Pat. No. 7,024,717 discloses radio signal communication between the handle of a tooth brush and a cleaning tool, and a memory element in the cleaning tool for storing data identifying the cleaning tool and indicating one or more operating parameters.
The present invention is directed to interventional catheter operating systems and adaptive components that allow different types of interventional catheter assemblies to be operated using a common control module and common operating systems. In particular, the present invention provides interventional catheter operating consoles having aspiration and/or infusion systems that can be used with a range of interventional catheters having aspiration and/or infusion capabilities, and to adaptive components such as tubing cassettes and controllers used to interface between the operating console and the interventional catheter.